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510(k) K071371

COPA AMD ANTIMICROBIAL WOUND DRESSING by Tyco Healthcare Group LP — Product Code FRO

K071371 is an FDA 510(k) premarket notification submitted by Tyco Healthcare Group LP for the device "COPA AMD ANTIMICROBIAL WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on November 19, 2007. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Tyco Healthcare Group LP has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2007
Date Received
May 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Tyco Healthcare Group LP

  • K080898 — AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE (May 5, 2008)
  • K063536 — POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING (January 29, 2007)
  • K060509 — PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING (June 23, 2006)
  • K060649 — GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 (May 22, 2006)
  • K010909 — NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE (April 9, 2001)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources